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on Bogus Supplements and Unproven Health Claims

The
FTC and FDA Finally Get Tough on Bogus Supplements and
Unproven Health Claims

Those
of you that regularly read this website know that I
am not a fan of the supplement industry or reference
to things outside of the mainstream as "alternative"
therapies. My opinion is that there should be therapies
that are proven to work, those that do not work, and
those that we don't know about yet. The shady part of
this industry has gotten bolder and bolder regarding
the outrageous health claims, so I am pretty happy that
the FTC and FDA has initiated a number of enforcement
actions.

Why
do I care so much about this? The thought of people
suffering and dying because they believe these claims
and not seeking conventional treatment makes me pretty
upset...

There
is a new Sheriff in town...

What
is driving part of this is the new head of the FDA,
Mark McClellan and Howard Beales, Director of the FTC's
Bureau of Consumer Protection who are both involved
in Operation Cure.All.

Word
is that McClellan is really shaking things up at the
FDA after only eight months in office. He has instituted
new changes such as speeding up approvals by reviewing
parts of NDAs (new drug applications) as they are submitted
to red flag issues early and trimming of multiple reviews.
Drug companies have been asking for these kind of changes
for some time. Also a sign of change is the announcement
that NCI and the FDA will collaboration to increase
the efficiency of cancer drug approvals.

No
patsy to the drug lobby, he has also instituted some
changes that are obviously not in the favor of big pharma.
Limiting the extensions on patents that delay introduction
of generics and forcing companies to report errors involving
their drugs to the FDA within 15 days are two proposals
which are not making any pharma CEO happy.

In
a bit of a split decision, the FDA is rumored to be
giving more leeway on health claims for foods but also
making them put more nutritional data on labels (hopefully
trans fatty acid content). I think this is a pretty
bad idea, since health claims could then be made for
foods without wide scientific agreement. Also, the recent
crackdown on the supplement industry is certainly a
welcome sign that the FTC and FDA will not sit by while
unproven claims are made.

Coral
Calcium

June
10 - The FTC charges the marketers of Coral Calcium
Supreme with "making false and unsubstantiated
claims about the product's health benefits." The
charges where "claiming, falsely and without substantiation,
that Coral Calcium Supreme can treat or cure cancer
and other diseases, such as multiple sclerosis and heart
disease. The FTC charges that these and other claims
go far beyond existing scientific evidence regarding
the recognized health benefits of calcium."

SeaSilver

June
19 - The FTC charged "false and unsubstantiated
claims about the health benefits and safety of a product
they market called "Seasilver"- a purported cure-all
liquid supplement. The FTC alleges that the defendants
promoted Seasilver as safe and effective to treat or
cure 650 diseases, including AIDS and cancers, and to
cause substantial and permanent weight loss." In
this enforcement action US Marshals seized over 130,000
bottles of Seasilver worth of $5 million dollars. The
federal court earlier froze the assets of the defendants
and the FTC is "seeking preliminary and permanent
injunctive relief, including restitution to consumers
who purchased the product." If the lawsuit is successful,
anyone who purchased the products under the belief of
false claims could get thier money refunded (or some
portion of it).

Also
noted in the FTC press release was the fact that Seasilver
had been cited for manufacturing facility violations.
This included allowing production line employees to
work in street clothes!!! Hardly sounds like GMP to
me...

Natural
Herbs and Supplements my Cialis

June
20 - The FDA issues a warning to consumers that the
following products: SIGRA, STAMINA Rx and STAMINA Rx
for Women, Y-Y, Spontane ES and Uroprin manufactured
by NVE, Inc., in Newton, N.J. and distributed by Hi-Tech
in Norcross, Ga were found to contain the Eli Lilly/ICOS
drug Cialis. These products were being marketed as dietary
supplements and were being sold over-the-counter claiming
to increase stamina, confidence and performance. Cialis
is approved in Europe for the treatment of erectile
dysfunction and is pending approval in the United States.

An
interaction between certain prescription drugs containing
nitrates and the active ingredient Cialis may cause
a drastic lowering of blood pressure. Erectile dysfunction
is often a common problem in people with diabetes, hypertension
(high blood pressure), hyperlipidemia (high cholesterol),
ischemic heart disease (nitrates are involved in treatment
of these diseases).

Below
are the FDA and FTC Tips for Consumers

The
FTC, the FDA, and other sister agencies have compiled
a list of valuable and reliable sources of health information
for consumers. The FTC Web site at www.ftc.gov/cureall,
and the FDA Web site at www.fda.gov, provides direct
links to these sources of information. Consumers are
encouraged to visit these Web sites when searching for
health information and ask the following questions before
deciding whether to purchase a health-related product:

What
is the product?

What
is the evidence that this product will do whatever
the product purports to do (e.g., counteract the
disease or medical condition being relieved; lead
to better results than conventional treatment?)

Have
results from studies of this product been published
in any peer-reviewed medical journals? Can I have
copies of the publications or references to these
publications?

NOTE:
The Commission authorizes the filing of a complaint
when it has "reason to believe" that the law has been
or is being violated, and it appears to the Commission
that a proceeding is in the public interest. The complaint
is not a finding or ruling that the defendant actually
has violated the law. The case will be decided by the
court.